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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COOK, INC. COOK MEDICAL .018 MICROPUNCTURE INTRODUCER, CATHETER

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COOK, INC. COOK MEDICAL .018 MICROPUNCTURE INTRODUCER, CATHETER Back to Search Results
Model Number MPIS-405-SST
Device Problems Unraveled Material (1664); Physical Resistance/Sticking (4012)
Patient Problem Device Embedded In Tissue or Plaque (3165)
Event Date 12/20/2021
Event Type  Injury  
Event Description
The left internal jugular vein was accessed with a micropuncture set under ultrasound guidance. The microwire went easily through the needle, but upon insertion of the microsheath, the wire unraveled along the inner mandrel. The surgeon attempted to extract the unraveled wire under fluoroscopic guidance. In the extraction process, the very tip of the unraveled wire was found to be stuck in the wall of the jugular vein, which surgeon confirmed using ultrasound. Surgeon pulled out what would come out, and left the remaining portion in the vein. It was clearly identifiable on fluoroscopy. Surgeon considered making an open incision to remove this piece of wire, but the risks would have far outweighed the benefit. Surgeon elected to leave the wire in place. Fda safety report id # (b)(4).
 
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Brand NameCOOK MEDICAL .018 MICROPUNCTURE
Type of DeviceINTRODUCER, CATHETER
Manufacturer (Section D)
COOK, INC.
MDR Report Key13087497
MDR Text Key282890220
Report NumberMW5106275
Device Sequence Number1
Product Code DYB
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Risk Manager
Type of Report Initial
Report Date 12/22/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/23/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberMPIS-405-SST
Device Lot Number14336024
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Is This a Reprocessed and Reused Single-Use Device? No

Patient Treatment Data
Date Received: 12/23/2021 Patient Sequence Number: 1
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